Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Differences in Change in Weight between Groups - waist circumference (cm)
研究概览
简要总结
This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.
详细描述
According to the National Institutes of Health, "obesity is one of the most daunting health challenges of the 21st century". Approximately 2/3 of all adults are overweight or obese. Efforts to abate the growing prevalence of obesity have not been successful. The Strategic Plan for NIH Obesity Research proposes preventing and treating obesity through lifestyle modification. The purpose of this study is to evaluate the effectiveness of a theory-based intervention framed within the Health Promotion Model (HPM) in facilitating weight loss and maintenance through promotion of healthy eating and physical activity among an underserved, vulnerable population of overweight or obese rural women aged 40-69. During these years, women experience increases in peri- and post-menopausal health risks that are magnified if they are overweight or obese. Weight loss will reduce risks and enhance functional status as they age. Maintenance of weight loss will be emphasized. The Internet offers a way to reach isolated rural women who have limited options for weight loss guidance. PUBLIC HEALTH RELEVANCE: Obesity is recognized as a major and growing public health problem. While many weight loss programs have been successful in the short term, they have not been successful in helping to maintain weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 40-69
- •overweight or Class I & II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance
- •state a commitment to losing weight
- •speak and read English
- •able to communicate over the telephone
- •able to use a computer with minimal assistance and complete electronic forms and surveys
- •have access to and are able to access the Internet
- •commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention
- •have or are willing to obtain an email account
- •have access to a DVD player
- •able to walk without an assistive device
- •answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active
排除标准
- •diagnosed with Type 1 diabetes
- •diagnosed with Type 2 diabetes and require insulin
- •≥ 10% weight loss in last six months
- •enrolled in a weight loss management program
- •enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation
- •taking medications that affect weight loss or weight gain
- •other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eating.
结局指标
主要结局
Differences in Change in Weight between Groups - waist circumference (cm)
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 1: Differences in Change in Weight between Groups - waist circumference (cm)
1: Differences in Change in Weight between Groups - Body Weight (kg)
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 1: The primary aim of the study was to compare the effectiveness of web-based only (WO) intervention with web-based interventions supplemented with peer-led discussion support group (WD) or professional email counseling (WE) for achieving change in the primary outcome of body weight between groups across three phases \[Phase I guided weight loss (baseline to 6 months), Phase 2 continued guided weight loss and weight maintenance over 12 months (6 months and 18 months), Phase 3 self-directed weight maintenance over 12 months (18 months and 30 months)\].
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 2: The secondary aim of the study was to compare the effectiveness of web-based only (WO) intervention with web-based interventions supplemented with peer-led discussion support group (WD) or professional email counseling (WE) for achieving change in primary outcomes of behavioral and biomarkers of healthy eating and activity between groups across three phases \[Phase I guided weight loss (baseline and 6 months), Phase 2 continued guided weight loss and weight maintenance over 12 months (6 months and 18 months), Phase 3 self-directed weight maintenance over 12 months (18 months and 30 months)\]
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids
时间窗: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids
次要结局
- Differences in Change in attaining Criterion-based Weight loss targets between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
- Differences in Change in attaining Criterion-based Healthy Eating between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
- Differences in Change in attaining Criterion-based Physical Activity between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)